Biotechnology and Food: Understanding the Issues Michael J. Phillips, Ph.D. Vice President...

Biotechnology and Food: Biotechnology and Food: Understanding the IssuesUnderstanding the Issues

Michael J. Phillips, Ph.D.Vice President

Biotechnology Industry Organization

National Public Policy Education ConferenceSeptember 22, 2003

Areas To CoverAreas To Cover

Adoption & BenefitsRegulatory PolicyLiability

Improvements most often Improvements most often delivered through biotechnologydelivered through biotechnology

Herbicide toleranceEnable improved weed control

measures

Insect resistanceEnable improved pest

management

Products in the MarketProducts in the Market

High-performance cooking oils -- reduce need for processing, create healthier food products (sunflower, peanuts, soybeans)

Delayed-ripening fruits and vegetables -- superior flavor, color, texture (tomatoes)

Food enzymes -- purer, more stable form of chymosin used in cheese production -- the first biotechnology food product

Global Area of Transgenic Crops, Global Area of Transgenic Crops, 1996 to 2000: 1996 to 2000: By CropBy Crop

(million hectares)(million hectares)

0

5

10

15

20

25

30

1996 1997 1998 1999 2000

Soybean

Corn

Cotton

Canola

Source: Clive James, 2000

Crops improved through Crops improved through biotechnology that are grown biotechnology that are grown

most frequently:most frequently:

SoybeansCornCottonCanola

Global Area of Transgenic Crops, Global Area of Transgenic Crops, 1996 to 2000: 1996 to 2000: By TraitBy Trait


0

5

10

15

20

25

30

35

1995 1996 1997 1998 1999 2000

Herbicide tolerance

Insect resistance

Herbicide tolerance /Insect resistance


Global Area of Transgenic Crops, 1996 to Global Area of Transgenic Crops, 1996 to 2000; Industrial and Developing Countries2000; Industrial and Developing Countries


0

5

10

15

20

25

30

35

40

1995 1996 1997 1998 1999 2000

Industrial

Developing


Global Area Adoption Rates (%) Global Area Adoption Rates (%) for Principal Transgenic Crops for Principal Transgenic Crops


020406080

100120140160

Soybean Cotton Canola Maize

Nontransgenic

Transgenic


Biotech Crops-Percent of Biotech Crops-Percent of Plantings - U.S.Plantings - U.S.

0

10

20

30

40

50

60

70

80

Soybeans Cotton Corn

19961997199819992000200120022003

% o

f T

otal

U. S

. Acr

eage

1999 figures are based on a survey of BIO member seed sales.2000-02 figures are based on USDA/NASS 2003 figures are estimates of USDA, NASS 3/31/03

2

13

37

47

54

6874

80

45

48

61

6971 70

25

37

252632 34

Biotech Crop Plantings-U.S.Biotech Crop Plantings-U.S.

0

10

20

30

40

50

60

Soybeans Cotton Corn

19961997199819992000200120022003*

# of

Acr

es P

l ant

ed (

Mil

l ion

s)

1

9

27

35

45.4

51.3 58.5

5.87

9.4 11.1 10.5

10

20

28.3

19.9

1925.3

26.9

*2003 estimates, USDA, NASS 3/31/03

Economic ImpactEconomic Impact

With crops improved through biotechnology, the key commodity is information, and this is carried in the seed itself. Further, its delivery is scale neutral and not capital intensive for the farmer.

Through the 8 crop varieties Through the 8 crop varieties widely planted in the U.S. to date, widely planted in the U.S. to date,

biotechnology has:biotechnology has:

Increased yields by 4 billion poundsSaved growers $1.2 billion annuallyReduced pesticide use by 46 million

pounds annually

-Leonard Gianessi National Center for Food and Agricultural Policy

If an additional 32 crop If an additional 32 crop varieties were adopted:varieties were adopted:

Crop yields would increase by an estimated 10 billion pounds

Costs to growers would be reduced by an additional $400 million annually

Further reduce pesticides by 117 million pounds

-Leonard Gianessi National Center for Food and Agricultural Policy

Granting Production & Import Approvals Granting Import Approvals Conducting Pre-Commercial Field Trials Commercialization Delayed

2002 Biotechnology

Science Based Regulatory Science Based Regulatory Systems AdvancingSystems Advancing

U.S. Coordinated FrameworkU.S. Coordinated FrameworkKey ConceptsKey Concepts

Federal “Safety Net”– All crops subject to science-based regulation with

individual products or categories eligible for exemption over time based on experience and data

– “Precautionary approach” adopted by U.S. in 1986– Ensure that biotechnology-derived crops are as safe

to grow as conventional crops– For crops intended for food or feed, ensure they are

as safe to eat as conventional crops


Department of Agriculture (USDA)– Plant Protection Act (PPA)– Animal Health Protection Act (AHPA)– Federal Seed Act (FSA)– Virus-Serum-Toxin Act (VSTA)

Animal biologics

– National Environmental Policy Act (NEPA)


Environmental Protection Agency (EPA)– Federal Insecticide, Fungicide & Rodenticide

Act (FIFRA) Health & environmental safety of pesticides

– Federal Food, Drug & Cosmetic Act (FFDCA) Dietary safety of pesticide residues

– Toxic Substances Control Act (TSCA) Health & environmental safety of other chemicals


Food and Drug Administration (FDA) –Federal Food, Drug & Cosmetic Act (FFDCA)– Food and feed

Safety of whole food and food ingredients “As safe as” conventional foods Significant changes may require food additive regulation

– Human drugs and biologics– Animal drugs– Medical devices

Anti-Biotech Myth #1Anti-Biotech Myth #1

Lack of Regulation– Products rushed to market– Little or no governmental oversight

Coordinated Framework Coordinated Framework Case StudyCase Study

Insect-resistant Corn (MON 810)Protected Against European Corn Borer and

Other Damaging Insect PestsBt (Bacillus thuringiensis) Insecticidal

Protein– Derived from naturally-occurring soil microbe– Used by conventional and organic farmers for 3

decades


1. Large-scale field tests, EPA/FIFRA, USDA/PPA (1992-96)

2. Small-scale field tests, USDA/PPA (1991)3. Determination not a plant pest,

USDA/PPA & environmental assessment, USDA/NEPA (1996)

4. Food safety/nutrition review, FDA/FFDCA (1996)


5. Health and environmental review and approval as plant-incorporated protectant (5-year) with tolerance exemption, EPA/FIFRA/FFDCA (1996-97)

6. Health and environmental reassessment and renewed approval (7-year), EPA/FIFRA/FFDCA (1998-2001)

Regulation – The RealityRegulation – The Reality Unprecedented Regulation of Plants and Plant

Products– Health, safety and environmental data reviewed by

three federal agencies over 11-year period 7 pre-commercial/4 post-commercial

– No comparable oversight for conventional hybrids

EPA/USDA/FDA– Jurisdiction uniformly exercised and consistently

recognized and supported by industry

Myth #2Myth #2

No Data

Data – Data – The Reality The Reality

Data Routinely Submitted to and Reviewed by USDA, EPA & FDA – 2000 NAS Report - App. B

www.nap.edu/catalog/9795.html

– Bibliography of health, safety & environmental studies www.agbios.com

New Data Requested As Needed– EPA for insect resistance and non-target impacts– USDA for outcrossing of virus-resistant squash

Myth #3Myth #3

No Public Participation

25-Year Record25-Year Record

Public MeetingsPublic CommentProposed Rules and PoliciesWeb SitesScientific Peer ReviewPublished Data

Public Participation – Public Participation – The Reality The Reality

Extensive Public Participation Opportunities Over the Past 25 Years

Myth #4Myth #4

Harm to Health and the Environment

Harm – Harm – The RealityThe Reality

With intensive governmental, academic and commercial oversight for the past 16 years, not a single instance of actual harm to health, safety or the environment has ever been confirmed for biotechnology derived crops on the market today.

Key Messages for Key Messages for BiotechnologyBiotechnology

Strong Federal Oversight– All products initially subject to review with individual

products or categories eligible for exemption over time– Clear, consistent rules developed with public

participation– Rigorous, science-based safety assessment by federal

regulatory agencies– Superior risk management

Conditions placed on approvals tailored to address potential risks

– Dynamic process – open to improvement based on experience and new scientific information

Let’s Get Real About Production Let’s Get Real About Production of Biotech Food and Feed Crops of Biotech Food and Feed Crops Federal agencies that regulate biotechnology crops

must address the potential for the unintended presence in conventional or organic crops of material from biotechnology-derived plants developed for food or feed use.

Must establish reasonable, science-based standards and procedures that acknowledge the realities of growing food, feed and fiber commodity crops in a biological system.

RealitiesRealities

1. Biological systems are inherently imperfect.

2. There is no such thing as “100 percent pure” in Mother Nature.

RealitiesRealities

3. Even Ivory Soap is “only” 99.44/100% Pure® and that is achieved through production in

carefully controlled industrial facilities.

RealitiesRealities

4. Biological systems are dynamic, not static.

5. Movement and dissemination of seeds and pollen is natural and inevitable. Wind Water Birds Insects

RealitiesRealities

6. The movement of genetic material (“gene flow”) is as normal and natural as agriculture itself. Pollen Seeds “Volunteers”

RealitiesRealities

7. Some plants are sexually promiscuous.

8. Crops and their weedy relatives have exchanged genes for centuries.

RealitiesRealities

9. Unintentional commingling of seed, grain, and other agricultural products, as well as processed commodities, occurs routinely in agricultural and food production. Seed in farm equipment Grain residues in shipping containers Food residues in the processing vat

RealitiesRealities

10. As analytical techniques continue to increase in sensitivity (chemical, biological & genetic), if we look hard enough, long enough and often enough, we are likely to find imperfections, impurities and contaminants just about everywhere.

Societal ResponseSocietal Response

Historically, the presence of unintended impurities in food, feed and seed has been recognized and accepted in laws, regulations and standards that establish allowances for these impurities or otherwise ensure that their presence is safe.


• Examples of existing allowances include: “Corn” must consist of at least 50% corn and

no more than 10% of other grains for which standards have been set (USDA)

“No. 1 Grade Corn” may include up to 2% broken corn and “foreign materials” (USDA)


Seed of a particular hybrid may contain up to 5% of a different hybrid without identification (USDA)

“Organic” products may include up to 5% of listed synthetic substances (including listed pesticides) and up to 5% of the EPA “tolerance” or allowable level for prohibited pesticides under the Organic Rule (USDA)


“Sugar Free” foods may contain up to 0.5 gram of sugar per serving (FDA)

“Nonfat Yogurt” may contain up to 0.5% milkfat (FDA)

“Decaffeinated” coffee may contain up to 3% caffeine (FDA)


Compound food ingredients that make up less than 5% of a food need not be further identified (CODEX)

An agricultural chemical for which a residue limit has not been set may legally be present in food up to the default action level of 0.1 ppm (Canada)

Societal ResponseSocietal Response• Example of an existing safety standard:

Naturally occurring substances that are not intentionally added to food may legally be present in the food if the amount of the substance “does not ordinarily render it injurious to health.” (Federal Food, Drug and Cosmetic Act)

DefinitionsDefinitions

• “Adventitious Presence” is a new term for an old concept.

• In its broadest sense, the concept refers to the unintended, incidental presence of an impurity in a product.

DefinitionsDefinitions

In the context of agricultural biotechnology, “adventitious presence” is the unintended, incidental occurrence of plant material from crops improved through modern biotechnology in seed, grain, food or feed products.

Why Do We Care?Why Do We Care?

• The presence of biotechnology-derived material in and of itself is not a health, safety or environmental concern. Historical lack of concern with conventional

crops Concern arises only if science establishes that the

presence of the biotechnology-derived material is found to present a risk (i.e., hazard x exposure), which is not the case.

Why Do We Care?Why Do We Care?

With intensive governmental, academic and commercial oversight for the past 16 years, not a single instance of actual harm to health, safety or the environment has ever been confirmed for biotechnology derived crops on the market today.

Reasons Why We Should Reasons Why We Should CareCare

1. Proactive product stewardship requires assurance of health and environmental safety.

2. Without a national policy, the “standard” becomes zero by default.

3. Some regulators view detection of DNA as a surrogate for the protein.


4. Potential economic impacts of unintended presence lead to calls for liability/compensation

5. Detection and sampling capabilities, not potential harm, are being used as basis for regulation and standard setting.

6. Each country going its own way undermines benefits of international harmonization.


All of these trends have the effect of: Undermining consumer confidence Causing unnecessary commercial/trade

disputes and market disruptions Adversely impacting growers and the rest

of the food and commodity industries Undermining investor confidence in crop

biotechnology

Key Issues Going ForwardKey Issues Going Forward• Build on the existing U.S. regulatory process for

early (field test stage) safety assessment of biotechnology-derived crops developed for food or feed use. Easily accommodated at FDA under same science-

based standards used for pre-market food safety reviews

Well-established review process for field tests at USDA and EPA

Key Issues Going ForwardKey Issues Going Forward• White House Office of Science &

Technology Policy took first step to:• Update field test requirements• Establish early food safety assessments

• Proposed Federal Actions• August 2, 2002• 67 Fed. Reg. 50578

Key Issues Going Forward Key Issues Going Forward

• Finalize proposed federal actions• Work with trading partners to harmonize

standards and policies to address the unintended presence of biotechnology-derived material from food and feed crops cleared for field testing and/or commercial introduction.

Let’s Get Real About Production Let’s Get Real About Production of Non-Food Biotech Cropsof Non-Food Biotech Crops

Federal agencies that regulate biotechnology crops must address the potential for the unintended presence in conventional or organic crops of material from biotechnology-derived plants intended not to be used for food or feed.

Must enforce reasonable, science-based standards and procedures to avoid unintended presence based on the realities of growing specialty crops in a biological system.

Plant-Made Pharmaceuticals Plant-Made Pharmaceuticals (PMPs) and Industrials (PMIPs)(PMPs) and Industrials (PMIPs)

Regulated by USDA at all stages of testing and production

Not subject to expedited review – Interim Final Rule (Aug. 6, 2003)– Permits always required for field testing – Permits required for commercial production for

foreseeable future

Not grown as commodity crops (e.g., contract growers only)

Plant-Made Pharmaceuticals and Plant-Made Pharmaceuticals and IndustrialsIndustrials

USDA’s principal focus is protecting health and environmental safety and agriculture

PMPs also regulated by FDA– More concerned about maintaining PMP’s purity

BIO White Paper for Confinement and Development of PMPs (5-17-02)

– Addresses protection of health and environmental safety, agriculture and PMP purity

– www.bio.org/pmp/PMPConfinementPaper.pdf


• USDA and FDA Guidance for Industry for PMPs:• Updated confinement measures• Addressed manufacturing, process, pre-

clinical and clinical testing considerations• September 12, 2002• 67 Fed. Reg. 57828


• USDA has tightened 2003 permit conditions for plants engineered to produce pharmaceutical and industrial compounds• March 10, 2003• 68 Fed. Reg. 11337• Comments by May 9, 2003


• Increased perimeter fallow zone (25’ to 50’)• Restricted next season plantings• Required dedicated equipment and storage

facilities• Required approved training programs• Increased isolation distance for open-pollinated

pharmaceutical corn to 1 mile• Increased field test inspections

Liability for Farming? Liability for Farming?

• Are biotechnology-derived crops regulated?

• Is the safety of these crops reviewed?• Do these crops grow differently than

others?• Can these crops co-exist with other types

of crops?

Regulation and SafetyRegulation and Safety

• Biotechnology-derived crops are regulated and reviewed for safety by two and sometimes three federal agencies

• Conditions placed on approvals tailored to address potential risks

• No comparable review or regulation of conventional or organic crops

Biotech Crops Grow Like All Biotech Crops Grow Like All Other Crops Other Crops

• Specific genetic changes made through molecular biology do not change the basic nature of the crop• Still pollinate exactly like their conventional

counterparts• Pose no more risk of cross-pollination with

neighboring crops than any other type of crop

Biotech Crops Grow Like All Biotech Crops Grow Like All Other CropsOther Crops

• Any open pollinating crop has the potential to cross-pollinate with another neighboring crop

• Growers of specialty crops protect against this:• Blue corn • Organic• White corn • “Non-GMO”• Canola


• Should a blue corn grower sue a yellow corn grower for planting too close?

• Should a sweet corn grower sue a field corn grower for planting too close?

• Should an organic grower sue a conventional grower for planting too close?


• Should you sue your neighbor whose grass makes you sneeze?

• Should your neighbor have to dig up his lawn and install a rock garden? “Native” grasses?

Co-existence With Other Crops Co-existence With Other Crops

• Specialty Growers Earn a Premium Price• They contract to meet certain standards• They assume the responsibility to meet those

standards• They take extra effort to meet those standards• They are rewarded with a premium price• They do not share premium with neighbors• Specialty crops include “Identity Preserved,” PMP,

PMIP and organic crops

Organic Crops Are Specialty Organic Crops Are Specialty Crops Crops

• “Organic” does not mean zero biotech• National Organic Program is process based• Organic grower who follows the standard but

still has detectable residue of a biotechnology-derived crop is not in violation

• Organic growers who contract for zero presence of biotechnology-derived material are assuming a contractual risk

Is There a Need for a New Is There a Need for a New Liability Scheme? Liability Scheme?

• Not based on safety • Not based on lack of regulation• Not based on unique pollen concerns• Not based on inability of growers to segregate

crops• Not based on requirement for new standards for

organic farming• Not based on lack of access to the courts

For More InformationFor More Information

www.bio.org

Biotechnology and Food: Understanding the Issues Michael J. Phillips, Ph.D. Vice President...

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